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Study to Evaluate Eflornithine + Lomustine vs Lomustine in Recurrent Anaplastic Astrocytoma (AA) Patients (STELLAR)

This study is currently recruiting participants.
Verified October 2017 by Orbus Therapeutics, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02796261
First Posted: June 10, 2016
Last Update Posted: October 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Orbus Therapeutics, Inc.
  Purpose
The purpose of this study is to compare the efficacy and safety of eflornithine in combination with lomustine, compared to lomustine taken alone, in treating patients whose anaplastic astrocytoma has recurred/progressed after radiation and temozolomide chemotherapy.

Condition Intervention Phase
Anaplastic Astrocytoma Recurrent Anaplastic Astrocytoma Drug: Eflornithine Drug: Lomustine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase 3 Open-Label Study To Evaluate the Efficacy and Safety of Eflornithine With Lomustine Compared to Lomustine Alone in Patients With AA That Progress/Recur After Irradiation and Adjuvant Temozolomide Chemotherapy

Resource links provided by NLM:


Further study details as provided by Orbus Therapeutics, Inc.:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 4 years ]

Secondary Outcome Measures:
  • Progression-free survival (PFS) [ Time Frame: 4 years ]
  • Objective response rate (ORR) [ Time Frame: 4 years ]

Other Outcome Measures:
  • Clinical benefit response (CBR) based on magnetic resonance imaging (MRI) criteria [ Time Frame: 4 years ]
  • OS rate at 18 months (OS-18) [ Time Frame: 18 months ]
  • Relevance of OS, PFS, ORR, and CBR to commonly used molecular/genetic biomarkers obtained from most recent pre-study tumor samples [ Time Frame: 4 years ]
  • Pharmacokinetic Analysis - Maximum concentrations (Cmax) of eflornithine in plasma will be determined. [ Time Frame: 1 Month ]
  • PK - Area under the curve (AUC) of eflornithine in plasma will be determined. [ Time Frame: 1 Month ]

Estimated Enrollment: 280
Study Start Date: July 2016
Estimated Study Completion Date: August 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Eflornithine + Lomustine
Eflornithine dosed on a 2 weeks on, 1 week off schedule + Lomustine dosed every 6 weeks
Drug: Eflornithine
Eflornithine 2.8 g/m2 administered orally every 8 hours on a 2 week on, 1 week off schedule
Other Name: DFMO
Drug: Lomustine
Lomustine 90 mg/m2 administered orally once every 6 weeks
Other Names:
  • CCNU
  • CeeNU
Active Comparator: Lomustine
Lomustine dosed every 6 weeks
Drug: Lomustine
Lomustine 110 mg/m2 administered orally once every 6 weeks
Other Names:
  • CCNU
  • CeeNU

Detailed Description:

This study will consist of 4 study periods of up to 50 months in total, consisting of:

Screening Period - A maximum screening duration of 4 weeks.

Treatment Period - Treatment Arm A up to 24 months; Treatment Arm B up to 12 months.

End of Treatment Visit - A minimum of 4 weeks post last treatment for both arms.

Follow-Up Period - Up to 24 months.

A total of approximately 280 patients will be randomized in a 1:1 ratio to receive either eflornithine + lomustine or lomustine alone.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients must meet all of the following inclusion criteria to be eligible for participation in this study:

  • Surgical or biopsy-proven diagnosis of WHO grade 3 AA.
  • Unequivocal evidence of first AA tumor progression or recurrence ≤ 3 months prior to randomization based on MRI criteria for tumor progression using enlarging Gd-contrast enhancement and/or T2 hyperintensity. Patients with non-measurable Gd contrast enhancing tumors will only be eligible if there is no necrosis seen on MRI and/or histopathological confirmation of AA per standard of care procedures is obtained.
  • First tumor progression or recurrence following surgical resection or biopsy, if resection is not feasible, EBRT and temozolomide chemotherapy.
  • Completion of EBRT ≥ 6 months prior to randomization.
  • A patient whose AA tumor has progressed or recurred and has had another surgical resection prior to randomization will be eligible if a) pathology review confirms AA, and b) post-surgical MRI demonstrates measurable tumor on T2/FLAIR.
  • Karnofsky Performance Status (KPS) score of ≥ 70.

Exclusion Criteria:

Patients who meet any of the following exclusion criteria are not eligible for study participation:

  • MRI defining progression is consistent with a diagnosis of glioblastoma or radiation necrosis.
  • Patients who are considered to be refractory to EBRT and temozolomide but who have not progressed.
  • Prior systemic therapy for recurrence of AA.
  • Presence of extracranial or leptomeningeal disease.
  • Prior lomustine use.
  • Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the patient unsuitable for the study.
  • Pregnant or breastfeeding.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796261


Contacts
Contact: Marietta Franco, MS 6504506634 marietta.franco@orbustherapeutics.com
Contact: Kathleen Villamejor, BS 6506569424 kathleen.villamejor@orbustherapeutics.com

  Show 79 Study Locations
Sponsors and Collaborators
Orbus Therapeutics, Inc.
Investigators
Study Director: Marietta Franco, MS Orbus Therapeutics, Inc.
  More Information

Responsible Party: Orbus Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02796261     History of Changes
Other Study ID Numbers: OT-15-001
First Submitted: June 3, 2016
First Posted: June 10, 2016
Last Update Posted: October 27, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Orbus Therapeutics, Inc.:
Anaplastic Astrocytoma
Grade 3 Glioma
Glioma
Eflornithine
Brain Cancer
Brain Tumor
Neuro-oncology
Progressive Anaplastic Astrocytoma
Recurrent Anaplastic Astrocytoma
Progressive Glioma
Recurrent Glioma
Malignant Glioma
Progressive Brain Tumor
Recurrent Brain Tumor

Additional relevant MeSH terms:
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Lomustine
Eflornithine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Ornithine Decarboxylase Inhibitors
Enzyme Inhibitors